BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7099803 · Received December 8, 2017

    Report

    Report Number
    1024879-2017-00552
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    October 24, 2016
    Report Date
    November 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673421
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: LOT NUMBER: 6131796, EXPIRATION DATE: 05/31/2018, MANUFACTURE DATE: 05/10/2016. LOT NUMBER: 6167802, EXPIRATION DATE: 06/30/2018, MANUFACTURE DATE:06/15/2016. RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR BLOOD LEAKAGE WITH THE INCIDENT LOTS WAS OBSERVED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED FOR TUBE PUSH OFF, AND CAPA (B)(4) HAS BEEN INITIATED TO DOCUMENT THE INVESTIGATION AND ROOT CAUSE ANALYSIS OF THE REPORTED INCIDENTS. REFER TO THE REFERENCED CAPA FOR RELATED CORRECTIVE AND PREVENTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET LEAKED BLOOD FROM THE CONNECTOR BETWEEN EXTENSION TUBING AND WHITE HUB ON 12 SEPARATE INSTANCES IN 2 LOT NUMBERS. NO SERIOUS INJURY, NO MEDICAL INTERVENTIONS. NO MUCOUS MEMBRANES EXPOSURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880738 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) SEE SECTION H.10. 00382903673421

    Patients

    Seq Age Sex Outcome Treatment
    1 Other